Pacerone Tablet
NDC Package 71610-787-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Pacerone (amiodarone hydrochloride) tablets is a medication used to treat certain types of serious (possibly fatal) irregular heartbeat (such as persistent ventricular fibrillation/tachycardia). This formulation utilizes a tablet delivery system. Marketed by Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 71610-787 and is authorized under FDA application ANDA075135.

Identification & Billing

NDC Package Code
71610-787-30
Package Description
30 TABLET in 1 BOTTLE
Product Code
71610-787
11-Digit Billing Format
71610078730
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Pacerone
Non-Proprietary Name
Amiodarone Hydrochloride
Substance Name
Amiodarone Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
AMIODARONE HYDROCHLORIDE 200 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat certain types of serious (possibly fatal) irregular heartbeat (such as persistent ventricular fibrillation/tachycardia). It is used to restore normal heart rhythm and maintain a regular, steady heartbeat. Amiodarone is known as an anti-arrhythmic drug. It works by blocking certain electrical signals in the heart that can cause an irregular heartbeat.

Regulatory & Marketing

Labeler Name
Aphena Pharma Solutions - Tennessee, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA075135
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-15-2010
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71610-787-30 identifies a specific commercial package of 30 tablet in 1 bottle of Pacerone, a human prescription drug labeled by Aphena Pharma Solutions - Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This tablet is formulated for oral use and contains amiodarone hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Aphena Pharma Solutions - Tennessee, Llc on November 15, 2010. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat certain types of serious (possibly fatal) irregular heartbeat (such as persistent ventricular fibrillation/tachycardia). It is used to restore normal heart rhythm and maintain a regular, steady heartbeat. Amiodarone is known as an anti-arrhythmic drug. It works by blocking certain electrical signals in the heart that can cause an irregular heartbeat.

How is this Aphena Pharma Solutions - Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71610078730. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
71610-787-30
11-Digit CMS (5-4-2)
71610-0787-30

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.